A
new draft of EU GMP Chapter 3 “Premises and Equipment” has been issued by the
European Medicines Agency.
The
main change from the previous draft is to section 6 as part of the improved
guidance on prevention of cross-contamination which states:
“3.6 Cross-contamination should be prevented
for all products by appropriate design and operation of manufacturing facilities.
The measures to prevent cross-contamination should be commensurate with the
risks. Quality Risk Management principles should be used to assess and control
the risks. Depending of the level of risk, it may be necessary to dedicate
premises and equipment for manufacturing and/or packaging operations to control
the risk presented by some medicinal products. Dedicated facilities are
required for manufacturing when a medicinal product presents a risk because:
the risk cannot be adequately controlled by operational and/ or technical
measures, scientific data from the toxicological evaluation does not support a
controllable risk (e.g. allergenic potential from highly sensitising materials
such as beta lactams) or relevant residue limits, derived from the toxicological
evaluation, cannot be satisfactorily determined by a validated analytical
method.”
Posted by Tim Sandle
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